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A randomised, open-label, multi-centre trial investigating the intra-subject variability of ROTEM® and TEG® parameters following two intravenous administrations of the same dose of activated recombina...

Update Il y a 4 ans
Reference: EUCTR2005-000891-42

A randomised, open-label, multi-centre trial investigating the intra-subject variability of ROTEM® and TEG® parameters following two intravenous administrations of the same dose of activated recombinant factor VII (rFVIIa/NovoSeven®) in haemophilia patients in a non-bleeding state

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Extract

• To evaluate the intra-subject variability (in vivo reproducibility) of thromboelastographic parameters as measured by ROTEM® and by TEG® prior to and at 15, 60, 120 and 240 minutes following two administrations of the same dose of activated recombinant human FVII (rFVIIa) in haemophilia patients in a non bleeding state

Inclusion criteria

  • Haemophilia

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